Bone screw with apertures

ABSTRACT

A bone screw includes a main body having a proximal end and a distal end. The main body extends along a longitudinal axis. The main body has an externally threaded surface that includes at least one helically extending thread having a minor diameter and a major diameter, which major diameter is greater than the minor diameter. The thread includes at least two flank surfaces extending between the minor diameter and the major diameter. The minor diameter of the thread defines a central portion of the main body. The thread may include at least one aperture that extends along an aperture axis through the thread between the flank surfaces.

The present application is a divisional of U.S. patent application Ser.No. 14/699,458 filed Apr. 29, 2015, which is entitled to the benefit ofand incorporates by reference essential subject matter disclosed in U.S.Provisional Patent Application Ser. No. 61/986,602, filed Apr. 30, 2014.

BACKGROUND OF THE INVENTION 1. Field of Invention

The present invention relates generally to surgical implants, and morespecifically to a bone screw with features that permit bone ingrowth.

2. Background Information

Fasteners are used in a variety of surgical applications includingaffixing implants to tissue and affixing tissue to tissue. A commonsurgical fastener is a bone screw, which comprises threads designed toachieve mechanical purchase within bone. Bone screws exist in a varietyof styles including pedicle screws, fracture fixation screws, and screwsfor securing bone plates. Bone screws are widely used because they areeasy to insert, easy to produce, and under certain conditions provideadequate mechanical purchase. However, in applications involving highlyporous, osteopenic or osteoporotic bone the efficacy of bone screws issubstantially reduced. Design optimization of bone screws for theseapplications is challenged by competing constraints; the need for larger(i.e. coarser) threads versus the need for adequate bending strength(e.g., provided by the minor diameter of a screw) versus the maximallyallowable major diameter (often limited by anatomy or mating componentgeometry). Further, bone screws function in a dynamic biologicalenvironment in which the supporting bone and tissue undergoes constantremodeling which can adversely affect the stability of the bone screwthrough time.

Design features aimed at improving the efficacy of bone screws withoutaffecting the conventional thread form have focused on enhancing theimplant-bone interface. Proposed enhancement have included use ofbiologically favorable metals (e.g. titanium), application of favorablecoatings (e.g. hydroxyapatite), and surface texturing.

Other design solutions departing from conventional thread forms haveincorporated features including expanding tips, trabecular metal, etc.These solutions may compromise the mechanical integrity of the screw.

Despite these proposed solutions, screw failure (e.g. loosening,breaking) is still a frequent clinical occurrence. Thus, the need existsfor a bone fixation device that can be delivered as easily as aconventional bone screw, allows for bone ingrowth, and maintainsadequate mechanical performance (e.g., pullout, bending).

SUMMARY

According to an aspect of the present disclosure, a bone screw isprovided that includes a main body having a proximal end and a distalend, which main body extends along a longitudinal axis. The main bodyhas an externally threaded surface that includes at least one helicallyextending thread having a minor diameter and a major diameter, whichmajor diameter is greater than the minor diameter. The thread includesat least two flank surfaces extending between the minor diameter and themajor diameter. The minor diameter of the thread defines a centralportion of the main body. The thread includes at least one aperture thatextends along an aperture axis through the thread between the flanksurfaces.

According to another aspect of the present disclosure, a bone screw isprovided that includes a main body having a proximal end and a distalend, which main body extends along a longitudinal axis. The main bodyhas an externally threaded surface that includes at least one helicallyextending thread having a minor diameter and a major diameter, whichmajor diameter is greater than the minor diameter. The thread includesat least two flank surfaces extending between the minor diameter and themajor diameter. The minor diameter of the thread defines a centralportion of the main body. The thread includes at least one recessdisposed within one of the flank surfaces.

According to another aspect of the present invention, a bone screw isprovided that includes a main body having a proximal end and a distalend, which main body extends along a longitudinal axis. The main bodyhas an externally threaded surface that includes at least one helicallyextending thread having a minor diameter and a major diameter, whichmajor diameter is greater than the minor diameter. The thread includesat least two flank surfaces extending between the minor diameter and themajor diameter. The minor diameter of the thread defines a centralportion of the main body, and the central portion includes a porousmaterial.

The various bone screw embodiments described herein can be used for avariety of surgical applications including use as pedicle screws andfracture fixation screws.

In certain of the disclosed embodiments the apertures provide space intowhich bone can grow. In other embodiments the apertures define astructure that allows the threads to locally deform and accommodatelocal changes in bone density. In other embodiments the aperturesaccommodate an insert formed of an osteoconductive, osteoinductive orosteogenic material.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a bone screw embodiment.

FIG. 2 is a cross-sectional view of the embodiment in FIG. 1.

FIG. 3 is a perspective view of a bone screw embodiment.

FIG. 3A is a distal end view of the bone screw embodiment shown in FIG.3.

FIG. 4 is a perspective view of a bone screw embodiment.

FIG. 4A is a distal end view of the bone screw embodiment shown in FIG.4.

FIG. 5 is a perspective view of a bone screw embodiment.

FIG. 5A is a distal end view of the bone screw embodiment shown in FIG.5.

FIG. 6 is a perspective view of a bone screw embodiment.

FIG. 6A is a distal end view of the bone screw embodiment shown in FIG.6.

FIG. 7 is a perspective view of a bone screw embodiment.

FIG. 7A is a distal end view of the bone screw embodiment shown in FIG.7.

FIG. 8 is a perspective exploded view of a bone screw embodiment.

FIG. 8A is a perspective view of the bone screw embodiment with insertsdisposed in the thread.

FIG. 9 is a perspective view of a bone screw embodiment.

FIG. 10 is a perspective view of a bone screw embodiment.

FIG. 11 is a diagrammatic sectional view of a threaded section portion.

FIG. 11A is a diagrammatic planar view of a threaded section portion.

FIG. 12 is a diagrammatic planar view of a threaded section portion.

FIG. 13 is a diagrammatic sectional view of a threaded section portion.

DETAILED DESCRIPTION

Referring to FIG. 1, a bone screw 1 according to the present disclosureincludes a main body 22 having a proximal end 2 and a distal end 3. Alongitudinal axis 4 extends between the proximal end 2 and the distalend 3. The main body 22 includes an externally threaded surface 24disposed between the proximal end and the distal end, which externallythreaded surface 24 includes at least one helically extending thread 9as will be described below.

The bone screw 1 may include a head 5 that is configured to allow thebone screw 1 to be rotationally driven (e.g., into a bone substrate).The present disclosure is not limited to any particular headconfiguration, and acceptable examples include a head 5 that can bedriven by a screw driver, and hex key, etc. The bone screw head 5 mayalso be configured to mate with a complimentary element such as thoseused within bone fixation devices (e.g., a pedicle screw), plates, etc.The embodiment shown in FIG. 1, for example, includes a recess 6configured to receive a hex key driver.

The portion of the main body 8 that includes the externally threadedsurface 24 may be cylindrically—shaped; i.e., the major diameter of thethread 9 disposed within the threaded surface 24 (described below) isconstant throughout substantially all the externally threaded surface 24as is shown in FIGS. 1-10. The present disclosure is not limited tohaving a cylindrically-shaped externally threaded surface 24, however;e.g., the externally threaded surface 24 may be tapered.

The main body 8 may include a tip portion 7 contiguous with the distalend 3, which tip portion 7 is configured to facilitate entry of the bonescrew 1 into a substrate (e.g., bone). Non-limiting examples of a tipportion 7 configured to facilitate entry of the bone screw 1 into asubstrate (e.g., bone) include a tip portion 7 having a tapered region(i.e., a region that decreases from a first diameter to a smaller seconddiameter located at the distal end 3), which tapered region may bethreaded, a tip portion having a self-tapping feature, or a tip portionhaving a self-drilling feature, or combinations thereof.

In some embodiments the bone screw 1 may include a shank portion 28disposed between the proximal end 2 and the externally threaded surface24.

The externally threaded surface 24 includes at least one helicallyextending thread 9 having a minor diameter 11 and a major diameter 12,which major diameter 12 is greater than the minor diameter 11. The majordiameter 12 is disposed at the outer most radial point of the thread 9,and the minor diameter 11 is disposed at the inner most radial point ofthe thread 9. The outer most radial point of the thread 9 may bereferred to as a “peak 15” of the thread 9, and the inner most radialpoint of the thread 9 may be referred to as a “root 32” of the thread 9.In those embodiments wherein the externally threaded surface 24 iscylindrically-shaped, an imaginary line drawn to intersect with themajor diameter points of the helical thread 9 is parallel with thelongitudinal axis 4 of the bone screw 1. In those embodiments whereinthe externally threaded surface 24 is tapered, an imaginary line drawnto intersect with the major diameter points of the helical thread 9 isnon-parallel with the longitudinal axis 4 of the bone screw 1. Thethread 4 is further defined by at least two flank surfaces 34 a, 34 bextending between the minor diameter 11 and the major diameter 12, whichflank surfaces 34 a, 34 b are disposed on opposite sides of the thread9. The minor diameter 11 of the externally threaded surface 24 defines acentral portion 36 of the main body 8.

The cross-sectional geometry of the helical thread 9 may be defined byparameters such as the major and minor diameters 11, 12, the flanksurfaces 34 a, 34 b, shape, and the pitch 12 of the helical thread 9. Inregards to the “shape” of the thread 9, the cross-sectional geometry ofthe thread 9 may reflect, for example, a symmetrical thread 9 havingflank surfaces 34 a, 34 b, each disposed at the same angle relative tothe longitudinal axis 4, or flank surfaces 34 a, 34 b disposed atdifferent angles, etc. As another example, the flank surfaces 34 a, 34 bmay intersect one another at the thread peak 15 (to form a pointedthread peak 15, or may not intersect one another (e.g., a truncatedthread peak 15). The present disclosure is not limited to any particularthread cross-sectional geometry.

The particular cross-sectional geometry of the helical thread 9 may beselected in view of the application. For example, one embodiment of thepresent bone screw 1 may have a helical thread 9 with a cross-sectionalgeometry that is well-suited for mechanical engagement with a first typeof substrate (e.g., porous bone, osteopenic bone, osteoporotic bone,etc.), while another embodiment of the present bone screw 1 may have ahelical thread 9 with a cross-sectional geometry that is well-suited formechanical engagement with a second type of substrate (e.g., dense bone,etc.). Embodiments of the present bone screw 1 may include more than onetype of helical thread 9, or a helical thread 9 that has a plurality ofcross-sectional geometries, each located at a different position.

To facilitate the description of the present disclosure, the variousbone screw embodiments depicted in the drawings are shown as havingsingle-lead right-handed threads 9. The present disclosure is notlimited to bone screws 1 having a single-lead right-handed thread 9. Forexample, embodiments of the present bone screw 1 may have a left-handedthread 9 and/or multiple lead threads 9.

In some embodiments of the present bone screw 1, the helically extendingthread 9 includes at least one aperture 13 extending through the thread9. The aperture(s) 13 extends along an aperture axis 38 through thethread 9, from flank surface 34 a to flank surface 34 b of the thread 9thereby providing an open passage through the body of the thread 9. Thepresent bone screw is limited to any particular orientation of theaperture axis 38 (e.g., relative to the longitudinal axis 4). Toillustrate a couple of exemplary aperture axis orientations, considerthe present bone screw in terms of a pair of orthogonal axes X and Y.Consider further that the longitudinal axis 4 is coincident with the Xaxis, and the Y axis extends radially outward from the X-axis. Referringto FIGS. 11 and 11A, a first aperture axis 38 may be described asextending along a line parallel to the longitudinal axis 4 (i.e.,parallel to the X-axis;) at a particular distance from the longitudinalaxis 4 (i.e., at a radial distance 48 out from the centrally locatedlongitudinal axis 4—see FIG. 11). FIG. 11A shows axis 38 and axis 4 asthe same because they are in the same radial plane. In FIG. 11A theradial distance 48 between axis 38 and axis 4 extends perpendicular(i.e., into) the 2-dimensional plane of the figure, and is therefore notshown. At the radial distance 48, the aperture axis 38 (and thereforethe aperture 13) passes through the flank surfaces 34 a, 34 b of thethread 9. In this example, because the aperture axis 38 is parallel withthe longitudinal axis 4, the aperture axis 38 is skewed by an angle β(i.e., the aperture axis 38 is non-perpendicular) to the centerline 50of the helically extending thread 9.

Now referring to FIG. 12, a second aperture axis example may bedescribed as extending along a line skewed from the longitudinal axis 4at a particular distance from the longitudinal axis 4 (i.e., at a radialdistance 48 (e.g., see FIG. 11) out from the centrally locatedlongitudinal axis 4). Here again, at the radial distance the apertureaxis 38 (and therefore the aperture 13) passes through the flanksurfaces 34 a, 34 b of the thread. In this example, the aperture axis 38is skewed from the longitudinal axis 4 by an angle α which orients theaperture axis 38 as perpendicular to the centerline 50 of the helicallyextending thread 9.

In some embodiments, the apertures 13 are disposed completely within thethread(s) 9, and therefore do not extend radially inward of the minordiameter 11 of the threaded surface portion 24 (i.e., no portion of anaperture 13 is disposed within the central portion 36). In theseembodiments because the entirety of the central portion 36 ismaintained, the mechanical properties (e.g., bending strength) of thebone screw 1 are not locally compromised by an aperture 13 traversingthe cylindrical central portion 36 defined by the minor diameter 11. Insome embodiments, one or more apertures 13 may extend radially inside ofthe minor diameter 11 and therefore into the central portion 36 of thethreaded surface portion 24 of the bone screw 1 (i.e., a portion of anaperture 13 is disposed within the central portion 36).

FIGS. 1-10 depict bone screw 1 embodiments having apertures 13 disposedwithin the helical thread 9 over substantially the entire externallythreaded surface portion 24. In alternate embodiments the apertures 13may be disposed within the helical thread 9 within less than theentirety of the externally threaded surface portion 24. For example, insome embodiments a portion of the helical thread 9 disposed adjacent thehead 5 may not include apertures 13. The specific placement of theapertures 13 can be chosen to customize the bone screw 1 for theapplication at hand; e.g., positioning the apertures 13 to provideincreased or decreased strength or deflection thread zones, zones wheremore bone affixation is desired, zones where inserts 618 (describedbelow) are desired, etc.

In some embodiments (e.g., see FIGS. 1 and 2), the apertures 13 arecircular shaped cross-sectional area. The circular apertures 13 are notlimited to any particular diameter. For example, in many applications abone screw 1 having circular apertures 13 with a diameter ofapproximately 1-2 mm is useful. The circular apertures 13 may, however,have smaller or larger diameters, or combinations thereof. The range ofacceptable aperture diameters is bounded by the minimum feature sizeinto which new bone would grow (˜100 microns) and a maximum feature sizethat provides adequate fastener bending strength.

Referring to FIGS. 3 and 3A, in another embodiment the apertures 113 ofbone screw 101 have a substantially trapezoidal shape. A substantiallytrapezoidal shape is defined as having a circumferentially extendingwidth 140 and a radially extending height 142 (e.g., see FIG. 3A). Thetrapezoidal aperture 113 configuration shown in FIG. 3 has a width 140greater than a height 142, thereby providing apertures 113 with agreater cross-sectional area as compared to the circular apertures 13depicted in FIGS. 1 and 2. Here apertures 113 are arrangedcircumferentially about the bone screw, with adjacent apertures 113circumferentially separated from one another by a thread portionhereinafter referred to as a strut 114. The struts 114 function toprovide support for the thread peak 115, which in this embodiment runsrelatively uninterrupted along the threads 109 and over the full lengthof the threaded surface 124. The strut 114 has a centerline 144. In someembodiments, a strut 114 may have a centerline 144 that extends along aline that extends radially outward from the longitudinal axis 4 (e.g.,see FIG. 3A). In some embodiments, a strut 414 may have a centerline 444that extends along a line that extends at an angle skewed from a radialline extending outward from the longitudinal axis 4 (e.g., see FIG. 6A).In certain embodiments a relatively uninterrupted thread peak 115 isadvantageous in that it provides a smooth bone contacting surface thatfacilitates insertion of the bone screw 101. In this embodiment theapertures 113 extending longitudinally along the length of the main body8 are coaxial to one another. In an alternate embodiment the apertures113 are not positioned in a coaxial fashion, but rather staggered suchthat when viewed on end an unobstructed line of sight through all theapertures 113 is not possible.

The embodiment shown in FIGS. 4 and 4A has substantiallytrapezoidal-shaped apertures 213, each having a width 240 less than aheight 242, thereby providing apertures 213 with a smallercross-sectional area. In this configuration, the size and number ofapertures 213 relative to the struts 214 provide a relatively stiffthread peak 215. The central portion 236 is shown in FIG. 4A.

FIGS. 5 and 5A depict a bone screw 301 embodiment in which the apertures313 have a greater cross-sectional area than the apertures 113 shown inFIG. 3; e.g., semi-annular shaped apertures. Here the size and number ofapertures 313 relative to struts 314 provides relatively more volumeinto which bone can grow. In certain embodiments there may be less thanone strut per revolution of the helical thread 309.

Still referring to FIGS. 5 and 5A, the individual aperture size (i.e.,the cross-sectional area) and total number of apertures 313 results in arelatively flexible thread peak 315. The flexible thread peak 315 isadvantageous in that during insertion of the bone screw 301 fastener itcan locally deflect to accommodate the geometry of the space it isfilling. For example, if the bone into which the bone screw 301 is beinginserted has a localized region of greater bone density, the flexiblethread peak 315 can elastically deforms as it passes that region. Afterpassing that region, the flexible thread peak 315 elastically returns toits nominal undeformed state. In this way the bone screw 301 is affixedto bone of non-homogeneous density and/or structure. In certainapplications it may be permissible or even advantageous for the flexiblethread peak 315 to plastically deform. The central portion 336 is shownin FIG. 5A.

Now referring to FIGS. 6 and 6A, in some embodiments, the apertures 413of bone screw 401 are shaped such that adjacent apertures 413 formstruts 414 favorably oriented to accommodate deformation of the flexiblethread peak 415. For example, as can be seen in FIG. 6A, adjacentapertures 413 can be configured to form struts 414 that extend at anangle skewed from a radial line extending out from the longitudinalaxis. In this configuration, under locally applied radial forces 416 thestruts 414 are primarily subject to bending forces rather thancompressive forces, allowing greater plastic deformation of the flexiblethread peak 415.

In some embodiments an aperture of bone screw may be defined by an “opengeometry” or an “open perimeter”; i.e., the aperture breaks through thepeak of the thread. For sake of clarity, an aperture having a “closedgeometry” or a “closed perimeter” is one in which the circumferentialperimeter of the aperture is continuous and therefore cannot be accessedthrough the peak of the thread. FIG. 7, for example, shows a bone screw501 with apertures 513 having slits 517 that interrupt the flexiblethread peak 515 and allow portions of flexible thread peak 515 to deformrelatively independently of other portions of the flexible thread peak515. The slits 517 can be relatively thin, and in certain embodimentsprovide physical contact or near contact between adjacent portions ofthe flexible thread peak 515. In this way one portion of the flexiblethread peak 515 provides displacement constraint for another portion ofthe flexible thread peak 515. In another embodiment, the slits 517 maybe configured to allow the entirety of the flexible thread peak 515 todeform and achieve an effective smaller major diameter over the entirelength of the shaft. When the bone screw 501 of this type having adiameter “X” is inserted into a hole with a diameter less than “X”, theflexible thread peak deforms to create an effectively smaller majordiameter. Once fully inserted, the flexible thread peak 515 provides arestorative radial force (i.e., a radially outward biasing force) thatacts to enhance mechanical purchase.

One function of the various aperture embodiments is to provide a volumeinto which bone can grow and form a mechanical interlock that resistsfastener loosening. Referring to FIGS. 8 and 8A, in an alternateembodiment the apertures 613 of bone screw 601 may be filled with amaterial other than the material of which the bone screw 1 is comprised.The material disposed in the apertures is referred to hereinafter as an“insert 618”. The present disclosure is not limited to any particularmanner of disposing the inserts 618 within the apertures. For example,the inserts 618 may be affixed with the apertures 613 by themanufacturer of the bone screw 601. Alternately, the inserts 618 may beaffixed to the bone screw at a time subsequent to the manufacture of thebone screw; e.g., at the time of surgery. As diagrammatically shown inFIG. 8, the inserts 618 may have a shape approximating the shape of thecorresponding aperture 613. One or more nominal dimensions of theinserts 618 may be larger than the corresponding dimension of theapertures 613 such that the inserts 618 are affixed to the bone screw601 via an interference fit. Alternately, the inserts 618 may be affixedusing an adhesive or a mechanical interlock. In other embodiments thepre-insertion shape of the insert 618 does not approximate the shape ofthe aperture 613. For example, an amorphous volume of granular autograftmaterial may be pressed into the apertures 613.

In some embodiments, the inserts 618 may be constructed to enhance thestability of the fastener within the bone, either immediately uponinsertion or through time. The inserts 618 may be constructed from avariety of known materials that provide or carry osteoconductive,osteoinductive or osteogenic elements including but not limited totricalcium phosphate, hydroxyapatite, bone morphogenic proteins,absorbable polymers, autograft, allograft, xenograft, and demineralizedbone matrix. In some embodiments the inserts 618 may be constructed ofmaterials that provide antimicrobial or antibacterial characteristics,including but not limited to drugs, silver, and bioglass. In someembodiments the insert 618 can be formed from an adhesive material, forexample polyurethane bone cement. Upon insertion of the fastener, theadhesive adheres to both the bone screw 601 and the bone, therebyenhancing initial bone screw stability. In another embodiment the insert618 expands upon insertion, filling voids within the bone and therebyenhancing initial bone screw stability. The present disclosure includesembodiments wherein all of the inserts 618 are the same material and/orconfiguration, and also embodiments where there are inserts 618 of afirst type material and/or configuration, and other inserts of adifferent type material and/or configuration.

The embodiment shown in FIG. 8 comprises apertures 613 positioned at asingle location along the perimeter of the shaft 608. In this andsimilar embodiments with fewer or smaller apertures the thread peak 615is relatively inflexible. Here the thread peak 615 and other threadportions 609 act to protect the insert 618 from damage or displacementduring fastener insertion.

Referring the FIG. 9, the struts 114 of bone screw 101 are comprised ofleading edges 119 and trailing edges 120. During rotational insertion ofthe fastener, the leading edges 119 follow the apertures 113 and thetrailing edges 120 follow the struts 114. In the embodiment shown inFIG. 9, both the leading edges 119 and trailing edges 120 of the struts114 are configured with a sharp edge (e.g., a pointed edge formed by therespective strut surfaces intersecting at an approximately 90-degreecorner). In some embodiments the leading edges 119 may be formed suchthat the respective strut surfaces intersect to form a rounded orchamfered edge that is less likely to catch or cut into adjacent bone.In some embodiments the trailing edges 120 may be formed to such thatthe respective strut surfaces intersect at an acute angle such that thetrailing edge 120 is effective at cutting bone. In some embodiments,both the leading edges 119 and trailing edges 120 are formed by an acuteangle within the strut 114 such that they are effective at cutting bone.

The specific aperture shape embodiments described above reflect some butnot all of the aperture shapes contemplated by the present disclosure.Consequently, the present disclosure is not limited to any particularaperture shape, and is not limited to just those aperture shapesdescribed above. In addition, a bone screw according to the presentdisclosure may include more than one type of bone screw apertures. Forexample, a first region of a bone screw 1 proximate the head 5 of thebone screw 1 may include one or more apertures 13 disposed within thehelical thread 9 of a first type (e.g., a first shape), and a secondregion of a bone screw 1 proximate the tip 7 of the bone screw 1 mayinclude one or more apertures 13 disposed within the helical thread 9 ofa second type (e.g., a second shape). Using a second type of aperture 13near the distal end 3 of the bone screw 1 where the tip 7 tapers and thethread major diameter 12 and minor diameter 11 vary can be beneficial.Hence, the present disclosure includes bone screw embodiments having aplurality of aperture types disposed at various positions along theexternally threaded surface, interdispersed aperture types, etc.

Although the embodiments shown in the FIGS. 1-12 depict apertures (i.e.hole features that pass completely through the threads), alternateembodiments may include one or more recesses 46 disposed within a flanksurface 34 a, 34 b of the helical thread 9 (e.g., see FIG. 13). A recess46 may be defined as a void open at a flank surface 34 a, 34 b, thatextends into the flank surface but does not extend entirely through thehelical thread 9 (i.e., it does not extend between flank surfaces tocreate a passage through the helical thread 9). These recesses 46 areconfigured (e.g., depth, width, height, and/or geometry) such that oncethe bone screw 1 is inserted, over time bone (or other tissue) mayextend into the recess 46 and thereby provide a mechanical interlockresisting screw loosening or backout. These recesses 46 may be orientedsubstantially parallel to the longitudinal axis 4 of the bone screw 1.In some embodiments of the present disclosure, the bone screw 1 mayinclude both recesses 46 and apertures 13 disposed within the helicalthread 9.

Referring to FIG. 10, in another embodiment the central portion of theexternally threaded surface includes an aperture network 713 thatincludes pathways that are oriented in multiple directions. For example,the central portion 736 (defined by the minor diameter) may include aporous structure favorable to bone growth into the pathways. Examples ofan acceptable material that can be used to form a porous structure partof the central portion include, for example, Porocoat® coating(available from DePuy Synthes, Inc.) or Trabecular Metal™ surfacetechnology (available from Zimmer, Inc.). The threads 709 that overlaythis aperture network 713 may be formed from a substantially solidmaterial. Thus, as the solid bone screw threads 709 engage a hole withina corresponding substrate (e.g., bone tissue), the threads 709 provide asmooth substrate contact surface that facilitates insertion. Theaperture network 713, which is in less intimate contact with bone duringinsertion, provides later access for bone ingrowth. Also, the solidthreads 709 enhance the rigidity and strength to the bone screw 701. Insome embodiments the pathway network created by the porous structure isdisposed in both a portion of the cylindrical region of shaftapproximately bounded by the minor thread diameter and a portion of thethreads. In this embodiment the thread peaks 715 are uninterrupted (i.e.without pores), providing a smooth bone interface surface.

Fabrication of the various embodiments may benefit from additivemanufacturing techniques (i.e. 3D printing). However, the scope ofinvention is not limited to a specific manufacturing technology.Embodiments may be manufactured from stainless steel, cobalt chromium,titanium, polymers, ceramics and other suitable materials.

In one fabrication method the bone screw 1 is comprised wholly of amaterial provided by an additive manufacturing process; e.g., printing.In another fabrication method a portion of the bone screw 1 is formed bya first process comprising conventional manufacturing techniques (e.g.machining, casting, rolling, stamping) and a portion of the bone screw 1is formed by a second process comprising additive manufacturingtechniques. By way of example, in one embodiment the central portion 36is formed using conventional manufacturing techniques and the thread 9is formed using additive manufacturing techniques.

Lastly, although this present disclosure is described herein as a bonescrew, the present disclosure device is not limited to bone screwapplications. These applications include but are not limited to othermedical applications (e.g. soft tissue anchors) and non-medicalapplications (e.g. screws for fastening wood, drywall and concrete).

Although the invention has been shown and described with respect tospecific detailed embodiments thereof, it will be understood by thoseskilled in the art that various changes in form and detail thereof maybe made without departing from the spirit and the scope of theinvention.

What is claimed is:
 1. A bone screw, comprising: a main body having aproximal end and a distal end, which main body extends along alongitudinal axis; the main body having an externally threaded surfacethat includes at least one helically extending thread having a minordiameter and a major diameter, which major diameter is greater than theminor diameter, and which thread includes at least two flank surfacesextending between the minor diameter and the major diameter; wherein theminor diameter of the thread defines a central portion of the main body;and wherein the thread includes at least one aperture that extends alongan aperture axis through the thread between the flank surfaces; and aninsert disposed within the at least one aperture.
 2. The bone screw ofclaim 1, wherein the insert comprises at least one of an osteoconductivematerial, an osteoinductive material, or an osteogenic material.
 3. Thebone screw of claim 2, wherein the insert comprises at least one oftricalcium phosphate, hydroxyapatite, bone morphogenic proteins,absorbable polymers, autograft, allograft, xenograft, or demineralizedbone matrix.
 4. The bone screw of claim 1, wherein the insert comprisesat least one of an antimicrobial material or an antibacterial material.5. The bone screw of claim 1, wherein the insert comprises an adhesivematerial.
 6. The bone screw of claim 1, wherein the at least two flanksurfaces extending between the minor diameter and the major diameterinclude a first flank surface extending between the minor diameter andthe major diameter and a second flank surface extending between theminor diameter and the major diameter, the first flank surface beingdisposed on the opposite side of the thread from the second flanksurface.
 7. The bone screw of claim 6, wherein the at least one apertureextends through the thread from the first flank surface to the secondflank surface, and the at least one aperture is defined by an outerradial surface, an inner radial surface, a first lateral surface, and asecond lateral surface, and the inner radial surface of the at least oneaperture is coincident with the minor diameter of the at least onehelically extending thread.
 8. The bone screw of claim 7, wherein theouter radial surface of the at least one aperture is disposed radiallyinside of the major diameter, and the at least one aperture has a closedperimeter.
 9. The bone screw of claim 8, wherein the at least oneaperture is configured to have a substantially trapezoidal shapedcross-sectional area.
 10. The bone screw of claim 1, wherein theexternally threaded surface of the main body extends a length, and theat least one aperture includes a plurality of the apertures disposed inthe thread at positions located throughout substantially all of theexternally threaded surface length, and each of the at least oneapertures includes an insert.
 11. The bone screw of claim 1, wherein theat least one aperture is defined by an outer radial surface, an innerradial surface, a first lateral surface, and a second lateral surface,and the inner radial surface of the at least one aperture is coincidentwith the minor diameter of the at least one helically extending thread;and wherein the outer radial surface extends a first circumferentialdistance between the first lateral surface and the second lateralsurface, and the inner radial surface extends a second circumferentialdistance between the first lateral surface and the second lateralsurface, and the first circumferential distance is greater than thesecond circumferential distance; and wherein the at least one apertureincludes a height extending between the outer radial surface and theinner radial surface, the height is less than second circumferentialdistance.
 12. A bone screw system, comprising: a bone screw comprising:a main body having a proximal end and a distal end, which main bodyextends along a longitudinal axis; the main body having an externallythreaded surface that includes at least one helically extending threadhaving a minor diameter and a major diameter, which major diameter isgreater than the minor diameter, and which thread includes at least twoflank surfaces extending between the minor diameter and the majordiameter; wherein the minor diameter of the thread defines a centralportion of the main body; and wherein the thread includes at least oneaperture disposed in at least one of the flank surfaces, the at leastone aperture configured to receive an insert; and at least one insertconfigured to be disposed within the at least one aperture.
 13. The bonescrew system of claim 12, wherein the insert comprises at least one ofan osteoconductive material, an osteoinductive material, or anosteogenic material.
 14. The bone screw system of claim 12, wherein theinsert comprises at least one of an antimicrobial material or anantibacterial material.
 15. The bone screw of claim 12, wherein theinsert comprises an adhesive material.
 16. The bone screw system ofclaim 12, wherein the at least two flank surfaces include a first flanksurface extending between the minor diameter and the major diameter anda second flank surface extending between the minor diameter and themajor diameter, the first flank surface being disposed on the oppositeside of the thread from the second flank surface; and wherein the atleast one aperture extends through the thread from the first flanksurface to the second flank surface.
 17. The bone screw system of claim12, wherein the at least one apertures is a recess disposed in at leastone of the flank surfaces.
 18. A bone screw, comprising: a main bodyhaving a proximal end and a distal end, which main body extends along alongitudinal axis; the main body having an externally threaded surfacethat includes at least one helically extending thread having a minordiameter and a major diameter, which major diameter is greater than theminor diameter, and which thread includes at least two flank surfacesextending between the minor diameter and the major diameter; wherein theminor diameter of the thread defines a central portion of the main body;and wherein the thread includes at least one recess disposed in one ofthe flank surfaces; and an insert disposed within the at least onerecess.
 19. The bone screw of claim 18, wherein the insert comprises atleast one of an osteoconductive material, an osteoinductive material, oran osteogenic material.
 20. The bone screw of claim 18, wherein theinsert comprises at least one of an antimicrobial material or anantibacterial material.
 21. The bone screw of claim 18, wherein theinsert comprises an adhesive material.